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FDA regulations for the manufacturing of pharmaceuticals, 21 CFR Part 11 "Electronic Records / Electronic Signatures."

Issue

  • Certificate for FDA regulations in the manufacturing of pharmaceuticals, 21 CFR Part 11 "Electronic Records / Electronic Signatures."
  • Can Building Operation incorporate a comment section to capture a reason for change made by an operator/user?

Product Line

EcoStruxure Building Operation

Environment

EcoStruxure Building Operation 3.0 and below

Cause

Building Operation site in need of the compliance certificate for 21 CFR Part 11 "Electronic Records / Electronic Signatures." Usually these are pharmaceutical manufacturing sites and the full FDA document PRT11Elect.pdf attached to this article.

Resolution

The current release of Building Operation has not addressed the pharmaceutical market and there is no electronic signature feature set at this time that meets the FDA regulations 21 CFR part 11.

A majority of life science end users are requesting the separation of critical environmental monitoring to align with the guidance in the ISPE GAMP Forum Position Paper "Use of Building Management Systems and Environmental Monitoring Systems in Regulated Environments," which recommends the segregation of critical monitoring into a separate Environmental Monitoring System (EMS) or Facilities Monitoring System (FMS) from the Building Management System (BMS). Many multinational corporations have already embraced this concept, as it reduces the scope of validation and results in lower Capex and Opex.

To align our approach with market needs, Schneider Electric has determined that a separate EMS is more desirable than a combined BMS / EMS solution. Eurotherm® helps us achieve this by monitoring the environmental conditions in validated GMP areas, while Building operation is used to control the HVAC systems in non-GMP areas.

For sales issues surrounding FDA regulations, please contact through your sales channel to the local Category Manager.

Americas: Americas.EcoStruxureBuilding@schneider-electric.com
EMEA: EMEA.EcoStruxureBuilding@schneider-electric.com
Asia Pacific: AsiaPac.EcoStruxureBuilding@schneider-electric.com
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